Open Letter to Federal Minister of Health

Re: Application for the registration of Ukrain in accordance with the Medical Specialities Order (Arzneispezilitätenordung) of 1976, repeated 1981.

Dear Minister,

I, Dipl.-Ing. Dr. Wassil Nowicky, take the liberty here of outlining the current problematic situation of the medicine Ukrain. I see it as extremely critical because, due to the present circumstances, many patients cannot continue their treatment because they are being denied access to the medicine.

Many human lives are at stake here, which is why I ask you to examine the following documentation carefully.

Firstly I would like to outline what I see as some important facts.

At a press conference on 25.01.2013 Dr. Aschhoff presented his results of treating children with Ukrain (Appendix 14) including a young girl with Ewing’s sarcoma who had been discharged from hospital with all treatment options exhausted and left to her fate (Appendix 17, page 36). Thanks to his help and the medicine Ukrain she survived her illness and is now working as a nurse. Another case showing very impressive results is that of Daniel B. (Appendix 18) suffering from xeroderma pigmentosum who had to undergo 56 operations before the age of 16. He began treatment with Dr. Aschhoff. Today he is 27 years-old and can work normally. It should be noted that this is the only case in the world of a xeroderma pigmentosum patient who has survived so long. Dr. Aschhoff has been able to help numerous children with Ukrain and has documented his successes, which can be found in the following publications: http://www.ncbi.nlm.nih.gov/pubmed/11062738, http://www.ncbi.nlm.nih.gov/pubmed/17591092.

Our children are certainly of the greatest importance in our lives. There is therefore almost nothing which can affect a parent so much as a child being diagnosed with cancer. The family’s world falls apart. Apart from the serious disease family members must face the inhuman consequences to be expected during the course of chemotherapy. Hair loss, caused by the highly destructive effect of the medicine on cells, inflammations which rage all over the body, constant vomiting and many other serious problems. If this ordeal is then a complete failure, it becomes clear to them that all these additional stresses and strains were of absolutely no avail and the child is more or less destroyed.

Since 1976 approximately 10,000 children have died of cancer in Austria. One can only have a vague idea of how much human suffering could have been avoided if Ukrain had been legally registered.

When I saw the first successes with Ukrain I presented the medicine at the 13th International Congress of Chemotherapy in Vienna in 1983 (Appendix 19), (Appendix 26, 27)(http://www.ukrin.com/docs/13.congress.pdf). At the time I was able to present documentation on more than 100 patients who had exhausted all other forms of therapy to document the efficacy of the preparation. Those patients who could not be completely cured with Ukrain at least experienced a considerable improvement in their quality of life. News of these successes understandably spread fast. The family of a 9 year-old girl diagnosed with Ewing’s sarcoma contacted me. After the girl had unsuccessfully undergone the conventional standard treatment of chemotherapy and cobalt therapy she was more or less sent home to die. X-rays confirm that the tumour had responded neither to radiation nor to chemotherapy and the tumour mass was steadily increasing. One month after ending chemotherapy she began treatment with Ukrain. At St. Anna Children’s Hospital Vienna it was observed that the tumour tissue was slowly regressing. The child was brought to Vienna regularly for follow-up examinations so that this case could be closely followed and documented at St. Anna Children’s Hospital (Appendix 17, page 37). As a result of this a second child for whom standard therapy had also proved ineffective was treated with Ukrain. It was a 3 year-old boy with generalised lymphangiomatosis, at the time completely emaciated and totally weakened (Appendix 20). He is now a young man of 23 years-old (http://ukrin.com/de/verhinderungstaktik-folgen).

In 1996 a complete tumour remission was also achieved during the course of Ukrain therapy with a 13 year-old girl with a large-cell astrocytoma who had also exhausted all forms of conventional therapy (Appendix 21). She is still alive today and has even given birth to a healthy child (http://www.ukrin.com/docs/steinacker_1996_2.pdf).

On 13.11.2012 Dr. med. Frank Daudert reported on his therapeutic success with a 7 year-old girl diagnosed with a brain tumour. “After 14 days I was astounded to see that her symptoms of paralysis were declining, the oblique position of the head had returned to normal and the child was again able to swallow. After a further 14 days the child once more attended the UNI-Klinik, Munich to check if the tumour was operable. During the course of further examinations it was found that the tumour had in fact reduced in size and the tumour was operable.

Each year in Austria approximately 200 child cancer sufferers are sent home to die with no hope of recovery. I offered St. Anna Children’s Hospital to provide Ukrain free of charge to treat 11 of these children but I have still not received an answer until now (Appendix 22) (http://ukrin.com/de/2011-01-13-brief-an-stanna-kinderspital).

Apart from these significant facts I now come to the events which have brought the current situation to a head.

On 04.09.2012 I was arrested without any reason and my staff, who were accused of being “members of a criminal organisation”, were also taken off for immediate questioning. All living and office premises were rummaged through, my family were terrorised for two weeks and private property was confiscated. The initial reason was an anonymous complaint. The second was another complaint from Ukraine from a relative of a patient who had been suffering from renal cancer with lung metastases. The patient was treated with Ukrain and died after five years (Appendix 28), whereby conventional medicine estimates survival time at a few months. The third reason is based on the case history of a patient who underwent Ukrain therapy for small-cell bronchial carcinoma with metastases and could ultimately not be cured. However, his quality of life was demonstrably improved (Appendix 29). Incomprehensibly the case histories of patients who had achieved complete remissions with Ukrain were also used against me. Witnesses were coerced into making statements which are demonstrably contrary to the facts. Documented correspondence with patients (Appendix 23) in which they express their gratitude is used in combination with witness statements (Appendix 24) to paint a totally different picture. This is incomprehensible to me and I can only attribute it to various methods of questioning (Appendix 25).

Here I quote from page 3, paragraph 8 of the initial report of 18.01.2012, Ministry of the Interior (GZ: 2 699606/1-II/BK/31o55), where the following can be found and which in my opinion makes clear the basic intentions of the authorities: “According to AGES criminal proceedings against NOWICKY have not so far been possible due to a lack of evidence and the unavailability of data on patients.” (http://ukrin.com/de/node/287)

Aside from these events I now come to the cause of this problematic situation, beginning with the refusal to grant registration. As can be seen from the chronological description of events in the appendix (Appendix 13), my application of 1976 for the registration of the preparation in accordance with the Medical Specialities Order valid at the time has still not been fully dealt with by the authorities.

There are decisions from the European Court of Human Rights in which it is judged contrary to Community law if an application is made, as I did, presenting the required documentation which is however then judged in accordance with a new amended law. The expression “pipeline justice” has developed in this respect. If an application is already in the “pipeline” (as for example my application in accordance with the Medical Specialities Order 1947) it should remain in the same “pipeline” until a decision is made (http://ukrin.com/de/sachverhalt).

As can be seen from the appendices, the legal requirements were always completely fulfilled. However, additional conditions were laid down by the authorities with no legal basis and I also fulfilled these as well as possible. In view of the fact that demands were made which could not be met in the case of cancer patients on moral and legal grounds (i.e. double-blind controlled studies with placebo) (http://www.ukrin.com/docs/Placebo_1995.pdf), they can only be interpreted as harassment as part of a strategy of prevention.

Referring again to the ECHR decisions on “pipeline justice” and the fact that my application in accordance with the Medical Specialities Order is still valid, I ask you most urgently to grant registration to the medical speciality Ukrain.

In any case, the principle of due process applies in Austria which means that the authorities are obliged to act in accordance with the law.

I can only repeat that the granting of registration would spare many families much suffering. Health insurance funds would pay for this efficient cancer therapy with negligible side-effects and the lives of many people could be saved.

Yours respectfully,

Dipl.-Ing. Dr. Wassil Nowicky

APPENDICES

Anti-cancer preparation Ukrain

How registration has been prevented

Until 1984 the Medical Specialities Order (Arzneispezialitätenordung) of 1947 was in force in Austria (http://www.ukrin.com/docs/1947-spezialitaetenordnung.pdf). According to this order it was only necessary to demonstrate the therapeutic benefit of a new preparation if it was produced from components that were already registered. Before 1984 comprehensive preclinical and clinical studies were not required.

In 1976 is was established that Ukrain has a selective effect. This means that it is only toxic for cancer cells but not for healthy cells (http://ukrain.ua/statti/038.HTM). It was also demonstrated that the preparation rapidly accumulates in cancer tissue, which can easily be seen through the autofluorescence of the substance in UV light (http://www.ukrin.com/docs/Hohenwarter_1992.pdf, http://www.ukrain.ua/present/ukrain.html). At the same time Ukrain is 300 times less toxic than its starting substances (http://www.ukrain.ua/statti/043.htm) and the therapeutic benefit was thus clearly to be seen. On 25 January 1980 I was granted the patent “Procedure for the production of new salts from alkaloid derivatives of thiophosphoric acid” (Austrian patent No. 354644) by the Austrian Patent Office.

On 27 July 1981 I wrote a letter to the minister Dr. Kurt Steyrer asking for a prompt decision on registration for the sake of future cancer prevention (http://www.ukrin.com/docs/1981-07-27-brief-zulassung-1981.pdf). In the reply from Minister Dr. Kurt Steyrer on 14 August 1981 I was informed that I needed a licence in order for the preparation to be registered. I made the relevant application. In 1988 I received a licence for the production of alkaloid derivatives and submitted it to the Federal Ministry of Health, Sport and Consumer Protection (http://www.ukrin.com/docs/Konzessionsdekret.pdf). In 1993 I received notice that I had to provide clinical studies carried out in accordance with the study plan approved by the ministry (http://www.ukrin.com/docs/Arrouas_1993.pdf).

In this kind of clinical study it was intended that various oncological diseases, as occur in the normal practice of urban and rural doctors, should be treated with Ukrain.

In 1996 such comparative studies with metastasising colorectal cancer were submitted to the ministry (http://www.ukrin.com/docs/Susak_1996.pdf). These studies showed that the survival rate (21 months) in the group treated with Ukrain was 78.6%; in the comparison group, treated with chemotherapy, the figure was only 33.3%.

Another study of colorectal cancer showed a fatal outcome in 25% of cases after 14 months of chemotherapy and X-ray radiation compared to only 8.3% in the group treated with Ukrain as monotherapy (http://www.ukrin.com/docs/Bondar_1998.pdf). With regard to the patients in this study, after 12 years 75% of the Ukrain group are alive compared to 45.8% in the group which received chemotherapy (http://ukrin.com/en/node/294, 2nd International Conference on Drug Discovery & Therapy February 1-4 2010 Dubai U.A.E.).

“Case Reports from Doctors, Scientists and Patients about Ukrain” was also submitted to the Federal Ministry of Health, Sport and Consumer Protection in 1996 (http://www.ukrin.com/docs/erfahrungsberichte.pdf). The doctors called for rapid registration.

In 1995 a report on the “Chemical, Pharmaceutical and Biological Documentation” was demanded. Mag. Kurt Vymazal drew this up and I then submitted it on 14 May 1995. In the chemical-pharmaceutical documentation Mag. Vymazal stated that the production of Ukrain was safe and the method of analysis sufficiently elaborated to confirm the quality of the preparation.

On 2 June 1995 my applications of 1976 and 1981 were rejected (Zl: 2.921.726/7-II/C/16b/95).

On 8 May 1995 the Ministry of Health demanded a placebo-controlled double-blind study (http://ukrin.com/de/node/293). These conditions are unacceptable for cancer patients on moral grounds and the Universitätsklinik für Frauenheilkunde in Vienna refused to carry out such a study.

After the results of the toxological study carried out abroad raised doubts on the part of the Ministry of Health, it was demanded that the preparation be examined in Austria at Forschungszentrum Seibersdorf. This demand was also met.

On 10 October 1996 Dr. Walter Knapp submitted his “Summary evaluation of the non-clinical data for the application for registration of the injection solution Ukrain, effective substance: Chelidonium Majus L. alkaloid thiophosphoric acid derivatives”, where he comes to the following conclusion: “In summary, the preclinical test results confirm that Ukrain has an interesting range of effects which make its use in the treatment of malignant diseases appear effective… The safety of Ukrain has also been confirmed by previous experience of clinical use with patients.” (http://ukrin.com/de/node/295, http://www.ukrin.com/de/tatsachen#klinischeanwendungen,

An expert assessor was then demanded for the clinical studies. Dr. Stefan Duma drew up a report which I submitted on 24 February 1997. Among other things Dr. Duma stated in his report: “The results of experimental and clinical studies show special efficacy of Ukrain therapy with adenocarcinomas.” (www.ukrin.com/docs/Duma_1997.pdf)

Subsequently a new demand was made that a report on the clinical data should be drawn up especially by DDr. Nahler. In his report he recommended the use of Ukrain stating, “The results of these few controlled clinical studies with Ukrain were always better than the control group… Ukrain appears to be better tolerated than other cancer therapies.” (http://www.ukrin.com/docs/ClinExpRep_2002.pdf)

Thereupon the Ministry of Health advised me to submit a supplementary application for patients who had exhausted all other forms of therapy. This application was supposed to receive rapid registration because the health insurance companies would then pay for the cost of treatment with Ukrain. This was why, on 05.032001, I made an application (GZ:921.726/13-VI/16/02) for the registration of Ukrain for patients who had exhausted all other forms of therapy.

Instead of granting this application, in an unusual step two further assessors were commissioned, possibly in order to find new reasons to reject the application. Despite the fact that I rejected one of the assessors as being biased, both assessors were accepted by the Ministry of Health. On the basis of their recommendation the application for registration as a medical speciality for patients who had exhausted all other forms of therapy under the proviso “after standard therapy has failed” was rejected in the shortest time with the notification of 25 April 2002 (GZ: 921.726/13-VI/16/02).

Prof. DDr. Winkler, assessor for non-clinical and clinical data, came to the conclusion, quoted from the notification GZ:921.726/13-VI/16/02: “Acute tolerance of the substance appears good” and then “In Part III it is not ascertained whether the observed effects can be attributed to the complex or to free alkaloids and/or free Thiotepa,” and therefore finally “Registration of Ukrain cannot be recommended.”

As chemical-pharmaceutical expert, Dr. Jean-Louis Robert (LUXMBURG) came to the conclusion, quoted from the notification: “Because the quality deficiencies are of a fundamental nature, this report declines to address individual points in detail.” The supposed quality deficiencies remained undefined in his report.

http://www.ukrin.com/docs/Knapp_1996.pdf) and the judgements of the Austrian Higher Administrative Court and the European Court of Human Rights, my applications of 1976 and 1981 have unlawfully still not been dealt with and procedural regulations have been breached.

Because this medicament with negligible side-effects has not been registered, cancer patients have been denied the chance of improving their quality of life or at least easing their suffering, prolonging their lives and in many cases even saving their lives without the usual almost inhuman side-effects of chemotherapy.